Scientific advances have brought us scores of new drugs in recent years. In the US, one major agency — the FDA — is responsible for making sure that the drugs they approve are safe and effective. Yet there were more than 14,000 drug recalls in the last 10 years, according to FDA statistics. That averages out to nearly four drug recalls a day!
Why are drug recalls so common, and how can you maximize safety when taking the medicines you need?
Why do so many drug recalls occur?
The FDA approves prescription drugs if research shows a medicine is safe and effective. Usually the risks are well known by the time approval is granted. For over-the-counter drugs, the bar is lower: proof that they work is not required, but the FDA still maintains oversight for safety.
Drug recalls are common because:
Are most drug recalls high-risk?
Fewer than one in 10 poses a serious health risk. The FDA grades risk severity for recalls as follows:
Between 80% and 90% of drug recalls are Class II.
In 2022, 6% of recalls were Class 1, 86% were Class II, and 7% were Class III.
How do drug recalls happen?